This two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development or need to provide the regulators with specific usability data for their device to comply with the MDR.
The format for the day will be interactive with the presenter sharing his experiences as a specialist with extensive knowledge and understanding of the requirements of the MDR, IEC 62366 and FDA human factors Guidance. There will be questions posed for discussion and delegates will work through some of the key aspects of performing a successful human factors study.
Benefits of attending
- Understand the requirements of IEC 62366 and FDA human factors Guidance
- Know how to provide the regulators with specific usability data for your device
- Understand human factors and the design process
- Learn how to validate combination products
- Consider human factors and risk
- Discuss generic combination products - ANDAs and HF
- Find out what HF data FDA require for biosimilars
Certifications:
- CPD: 12 hours for your records
- Certificate of completion
Course Content
Introduction
Background to human factors
Legal and regulatory requirements
IEC62366, FDA guidance and expectations
Human factors methods and best practices
Design control, design and development
User needs & user interface specifications
Formative and validation testing methods
Use-related risk
HF and clinical trials
Technical data requirements
Predicate devices, platform devices and post-market surveillance
Generic devices, biosimilars and ANDAs
Practicalities - how to stay legal
Wrap-up
Who Should Attend
This event will be beneficial to those working in the following areas:
- Engineering and device development
- Packaging
- Regulatory affairs
- Quality systems
- Quality assurance
- Risk management
- Marketing
- Usability and human factors engineering
